Benign Esophageal StrictureBIDARCANCT03189927
BD-Covered Stent for Benign Esophageal Strictures: a Safety and Feasibility Study
A study testing BD-Covered esophageal stent in people with Benign Esophageal Stricture, run by Radboud University Medical Center.
Trial summary
A non-randomized prospective clinical, pilot study in a single centre assessing the safety and feasibility of the esophageal biodegradable covered stent for refractory benign esophageal strictures with or without fistulae Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Esophageal Stricture
- What is being tested?
- BD-Covered esophageal stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2017to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects of both genders
- Age ≥ 18 years
- Appropriate cultural level and understanding of the study
- Willingness to participate voluntarily in the study and give written informed consent
- Refractory benign esophageal stricture with or without fistulae, i.e. the patient has to pass a minimum of 2 and a maximum of 10 failed esophageal dilations to the minimal diameter of 15-mm, using a pneumatic balloon dilator or Savary bougie, not complicated by or malignancy.
- Ability to undergo periodic endoscopic follow-up.
Who cannot join
- Pregnancy or breastfeeding
- Simultaneous participation in another clinical study
- Life expectancy of less than 12 months
- Malignant esophageal stricture
- Stenosis after laryngectomy, or if the distance between the upper edge of the stent is less than 2 cm from the upper esophageal sphincter
- Undergone an esophageal stent implantation before.
Trial locations and contacts
No sites are listed yet.
About this study
A non-randomized prospective clinical, pilot study in a single centre assessing the safety and feasibility of the esophageal biodegradable covered stent for refractory benign esophageal strictures with or without fistulae
Read the detailed description
A non-randomized prospective clinical, pilot study in a single centre assessing the safety and feasibility of the esophageal biodegradable covered stent for refractory benign esophageal strictures with or without fistulae. The follow-up will be 6 months form implantation. After 3 months a control endoscopy will take place to evaluate stent and degradation process.
- Conditions
- Benign Esophageal Stricture
- Being tested
- BD-Covered esophageal stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BD-Covered esophageal stentDevice
a biodegradable covered stent is implanted to achieve a long-term relieve of dysphagia in refractory benign esophageal strictures
| Study group | Role | What they receive |
|---|---|---|
| BD-Covered stent | Experimental | Device: BD-Covered stent for refractory benign esophageal strictures with of without fistulae Receives: Device: BD-Covered esophageal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment associated adverse events during follow-up (safety)
Short term (within 7 days after treatment) and long term (after 7 days) major complications and minor complications. Major complications are defined as life threatening and severe complications such as perforation, haemorrhage, fistula formation and severe pain. Minor complications are defined as non-life threatening or moderately severe pain and gastroesophageal reflux.
Measured: 6 months
BD-Covered stent placement (feasibility): (1) ease of deployment at intended esophageal location and, (2) incidence of device related adverse events at moment of stent placement
Technical success is defined as ease of deployment and placement of the BD-Covered stent at the required esophageal location.
Measured: 1 day
Secondary outcomes (2)
Esophageal pain, measured with VAS during follow-up after stent placement
Pain will be measured with the VAS during follow-up
Measured: 6 months
Recurrent dysphagia, measured with Ogilvie dysphagia score, during follow-up
Recurrent dysphagia during follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start1 Jul 2017 (estimated)
- Primary completion1 Jul 2018 (estimated)
- Study completion1 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Esophageal StrictureStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ELLA-CS , sro
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189927
- Sponsor's protocol ID
- NL.59222.091.16
- Acronym
- BIDARCA
- Status last verified
- May 2017
- First submitted
- 29 May 2017
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BD-Covered Stent for Benign Esophageal Strictures: a Safety and Feasibility Study
- ClinicalTrials.gov ID
- NCT03189927
- Acronym / sponsor ID
- BIDARCA / NL.59222.091.16
- Conditions
- Benign Esophageal Stricture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ELLA-CS , sro
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A non-randomized prospective clinical, pilot study in a single centre assessing the safety and feasibility of the esophageal biodegradable covered stent for refractory benign esophageal strictures with or without fistulae
Detailed description
A non-randomized prospective clinical, pilot study in a single centre assessing the safety and feasibility of the esophageal biodegradable covered stent for refractory benign esophageal strictures with or without fistulae. The follow-up will be 6 months form implantation. After 3 months a control endoscopy will take place to evaluate stent and degradation process.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BD-Covered stent | Experimental | Device: BD-Covered esophageal stentDevice: BD-Covered stent for refractory benign esophageal strictures with of without fistulae |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects of both genders
- Age ≥ 18 years
- Appropriate cultural level and understanding of the study
- Willingness to participate voluntarily in the study and give written informed consent
- Refractory benign esophageal stricture with or without fistulae, i.e. the patient has to pass a minimum of 2 and a maximum of 10 failed esophageal dilations to the minimal diameter of 15-mm, using a pneumatic balloon dilator or Savary bougie, not complicated by or malignancy.
Key exclusion criteria (6 listed)
- Pregnancy or breastfeeding
- Simultaneous participation in another clinical study
- Life expectancy of less than 12 months
- Malignant esophageal stricture
- Stenosis after laryngectomy, or if the distance between the upper edge of the stent is less than 2 cm from the upper esophageal sphincter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BD-Covered esophageal stenta biodegradable covered stent is implanted to achieve a long-term relieve of dysphagia in refractory benign esophageal strictures | Device | BD-Covered stent |
Primary outcome
Incidence of treatment associated adverse events during follow-up (safety)
Time frame: 6 months
Short term (within 7 days after treatment) and long term (after 7 days) major complications and minor complications. Major complications are defined as life threatening and severe complications such as perforation, haemorrhage, fistula formation and severe pain. Minor complications are defined as non-life threatening or moderately severe pain and gastroesophageal reflux.
BD-Covered stent placement (feasibility): (1) ease of deployment at intended esophageal location and, (2) incidence of device related adverse events at moment of stent placement
Time frame: 1 day
Technical success is defined as ease of deployment and placement of the BD-Covered stent at the required esophageal location.
2 secondary outcomes
Esophageal pain, measured with VAS during follow-up after stent placement
Time frame: 6 months
Recurrent dysphagia, measured with Ogilvie dysphagia score, during follow-up
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Individual participant dataSharing planned: No
Related trials for Benign Esophageal Stricture
Recruiting
Early Versus Late Endoscopic Stenting for Refractory Benign Esophageal Strictures
Refractory Benign Esophageal Strictures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing BD-Covered esophageal stent in people with Benign Esophageal Stricture, run by Radboud University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bram Vermeulen, Drs. (0611079557 ext. +31, bram.vermeulen@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment associated adverse events during follow-up (safety) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2017; AzTrials last refreshed its copy on 6 Nov 2026.